§73.300 食品着色剂胡萝卜油(Carrot oil)

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    更多关于美国 FDA 21 CFR 第 73 部分的内容，请详见美国FDA 21 CFR 第73部分关于免除产品证书的食品用着色剂种类汇总

　　§ 73.300   Carrot oil.

　　（a） Identity. （1） The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots （ Daucus carota L.） with subsequent removal of the hexane by vacuum distillation. The resultant mixture of solid and liquid extractives consists chiefly of oils, fats, waxes, and carrotenoids naturally occurring in carrots. The definition of carrot oil in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for carrot oil or carrot oleoresin under section 401 of the act.

　　（2） Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

　　（b） Specifications. Carrot oil shall contain no more than 25 parts per million of hexane.

　　（c） Uses and restrictions. Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless the use of added color is authorized by such standards.

　　（d） Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.

　　（e） Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721（c） of the act.

　　§73.300　胡萝卜油

　　（a）特性：

　　（1）着色剂胡萝卜油呈液状或固体状，系由食用胡萝卜（Daucus carota L.）用己烷提取后所得的混合物经真空蒸馏法除去己烷而得。固体或液体萃取物中的主要组分有天然存在于胡萝卜中的油、脂、蜡和类胡萝卜素。本栏所指的胡萝卜油，仅指用做着色剂的胡萝卜油，不同于法规401节中所指的具有法定标准的胡萝卜油或胡萝卜油树脂。

　　（2）用胡萝卜油配制成的食用着色剂混合物，只能选用本分部所列安全和适用于食品着色的着色剂混合物稀释剂。

　　（b）质量规格：胡萝卜油中所含的己烷量，不得超过25mg?kg。

　　（c）使用和限制条件：胡萝卜油在符合GMP用量条件下，可安全地用于一般食品的着色，但不得用于本法规§401中颁布的已确定标准的食品的着色，除非所加入的色素是这类标准所允许的。

　　（d）标签标注方式：本着色剂和任何含有本着色剂的混合物，拟单独使用或起部分着色效果时，除法规所规定的其它所需说明外，其标签还应符合本章§70.25中的规定。

　　（e）免除产品证书：本着色剂免除产品证书以保护公众健康。所生产的每批产品也免除按法规§721（c）中所规定需要产品证书。